An external artificial urinary sphincter device

Abstract

The application provides an external artificial urethral sphincter device, adopts an external double air bag pressure control structure design, adjusts the size of the pressure of the air bag on the urethra by controlling the size of the inflation amount of the air bag, and realizes free urine control. Through the double air bag integrated design, the volume of the device is reduced, the device is convenient to carry, the image of the patient is maintained during use, and the experience of the patient is improved. The external artificial urethral sphincter device saves the cost of the artificial urethral sphincter implantation surgery and reduces the economic pressure of the patient. In addition, the structure of the external artificial urethral sphincter device is similar to the shape of the penis, when inflated, the extrusion force generated on the two sides of the air bag for fixing the penis is offset by the force for extruding the air bag, the aorta of the penis is prevented from being extruded, and tissue necrosis is prevented.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an external artificial urethral sphincter device. BACKGROUND

[0002] With the increasing social pressure, the incidence of prostate disease is increasing, and no matter how the treatment is, it will cause different degrees of damage to the urethral sphincter and cause urinary incontinence. In addition to the treatment of prostate disease, male urinary incontinence also includes common safety accidents such as pelvic fractures or urethral injuries caused by work injuries and traffic accidents.

[0003] The existing urinary incontinence treatment method usually adopts two ways of artificial urethral sphincter implantation surgery and penis clamp. The artificial urethral sphincter is AMS800 system developed by AMS company, which is composed of water storage bag, sleeve, control pump and pipeline connecting three parts. The pressurization system and the pressure reduction system are ingeniously combined into the control pump, which simplifies the implantation surgery and promotes the wide application of artificial sphincter, but the price is high, the surgical repair rate is high, and the complete urinary control proportion is limited. The penis clamp is composed of torsional spring, upper clamp rod, lower clamp rod and spherical handle, which has low use cost and high reliability, but the penis clamp has too much force or long-term indwelling penis clamp, which is easy to cause local ischemic necrosis of the penis. In addition, it can also be achieved by indwelling catheter, cystostomy tube or wearing paper diaper, but these ways have the disadvantages of affecting the image of the patient, poor user experience, many complications and the like.

[0004] Patent No. 202010040409.1 discloses an external artificial urethral sphincter device, which comprises a ring-shaped pressure regulating bag, a pump, a hose and a sleeve bag. The sleeve bag is provided with an inflation bag, a buffer layer and a through hole. The scheme is to set a pressure regulating bag below the penis, the upper end of the air bag is provided with a buffer layer, and the air bag is inflated by the pump to control the urethra. Although the device can control the urethra, the gap in the penis of the device is large, and the device may be loose on the penis when the air bag is inflated to press the urethra, thereby affecting the urinary control effect of the device. Therefore, the existing traditional device needs to be improved. SUMMARY

[0005] In order to overcome the shortcomings of the prior art, the present application provides an external artificial urethral sphincter device, which can firmly fix the device on the penis without causing extrusion to the arteria pudendalis communis, and can freely control the inflation amount of the air bag to realize pressure control of the urethra, thereby achieving the effect of free urinary control.

[0006] In order to achieve the above purpose, the present application provides an external artificial urethral sphincter device, which comprises a ring-shaped ring for sleeving on the penis and an air bag on the inner wall of the ring-shaped ring. The air bag comprises an air bag for fixing the penis and an air bag for extruding the penis.

[0007] According to some embodiments of the present application, the air bag for fixing the penis comprises a first fixing air bag and a second fixing air bag, and the air bag for pressing the penis is located between the first fixing air bag and the second fixing air bag.

[0008] According to some embodiments of the present application, the inner wall of the top of the air bag for fixing the penis is provided with a gap corresponding to the aorta of the penis.

[0009] According to some embodiments of the present application, the air bag for fixing the penis comprises an arc-shaped main body and a buffer at the end of the main body.

[0010] According to some embodiments of the present application, the inward movement distance of the top of the arc-shaped main body is smaller than the inward movement distance of the buffer at the end of the main body.

[0011] According to some embodiments of the present application, the main body of the air bag for fixing the penis has a first elastic part that can be stretched and contracted, and the main body of the air bag for fixing the penis is stretched and contracted along the center of the ring by the first elastic part.

[0012] According to some embodiments of the present application, the main body of the air bag for fixing the penis is provided with a smooth first contact surface, and the first contact surface of the main body of the air bag for fixing the penis is in contact with the penis after being inflated.

[0013] According to some embodiments of the present application, the air bag for pressing the penis has a second elastic part that can be stretched and contracted at the side, and a second contact surface at the top of the air bag for pressing the penis, and the air bag for pressing the penis is stretched and contracted along the center of the ring by the second elastic part.

[0014] According to some embodiments of the present application, the inward movement distance of the air bag for pressing the penis is greater than the inward movement distance of the air bag for fixing the penis.

[0015] According to some embodiments of the present application, the device further comprises an inflation port for inflation, the inflation port comprises a fixing inflation port and a pressing inflation port, the first fixing air bag and the second fixing air bag are in communication, the fixing inflation port inflates the first fixing air bag and the second fixing air bag at the same time, and the pressing inflation port inflates the air bag for pressing the penis.

[0016] Advantages:

[0017] Compared with the prior art, the external artificial urethral sphincter device provided by the application adopts an external double air bag pressure control structure design, adjusts the pressure of the air bag on the urethra by controlling the size of the inflation amount of the air bag, and realizes free urine control. Through the double air bag integrated design, the size of the device is reduced, convenient to carry, and the patient's image is maintained during use, improving the patient's experience. The external artificial urethral sphincter device saves the cost of artificial urethral sphincter implantation surgery and reduces the economic pressure of patients. In addition, the external artificial urethral sphincter device has a structure similar to the shape of the penis, and when inflated, the extrusion force generated on both sides of the air bag for fixing the penis is offset by the force for extruding the air bag, avoiding the extrusion of the aorta of the penis and preventing tissue necrosis.

[0018] In order to make the above and other objects, features and advantages of the present application more apparent, the following will specifically describe a preferred embodiment of the present application with reference to the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0019] Figure 1 A structure diagram of an external artificial urethral sphincter device provided by the application;

[0020] Figure 2 A force diagram of the air bag for fixing the penis extruding the penis in the external artificial urethral sphincter device provided by the application;

[0021] Figure 3 A schematic diagram of the external artificial urethral sphincter device provided by the application extruding the penis after inflation;

[0022] Figure 4 A force diagram between the air bag for fixing the penis and the air bag for extruding the penis in the external artificial urethral sphincter device provided by the application;

[0023] Figure 5 A cross-sectional view of the external artificial urethral sphincter device provided by the application. DETAILED DESCRIPTION

[0024] As Figure 1As shown, the external artificial urethral sphincter device provided by the application comprises a ring 1 for sleeving on the penis and an air bag 2 on the inner wall of the ring, wherein the air bag 2 comprises an air bag 20 for fixing the penis and an air bag 21 for pressing the penis. The device combines the structure of the penis and the position of the large artery in the penis, and is provided with the air bag 20 for fixing the penis and the air bag 21 for pressing the penis, which can realize free urine control. In use, the ring 1 is sleeved on the penis, the air bag 20 for fixing the penis is inflated first to stably fix the ring 1 on the penis, and then the air bag 2 for pressing the penis is inflated, and the air bag 21 for pressing the penis presses the urethra on the lower surface of the penis inward to realize the function of free urine closing. When urination is needed, the air in the air bag 21 for pressing the penis is exhausted to cancel the pressing force on the lower surface of the penis, thereby realizing the effect of urination. The ring 1 and the air bag 2 of the device adopt an integrated structure design, the air bag 20 for fixing the penis is inflated to fix the position on the penis, and then the patient can inflate and deflate the air bag 21 for pressing the penis freely, so that the device can realize the function of free urine control of the user, and the device does not need to be taken off from the penis, and the structure design is small and convenient to carry, thereby improving the comfort of the user. The device is made of TPU flexible material and has strong flexibility, and the air bag 1 can better fit the penis during inflation.

[0025] In this embodiment, the air bag 20 for fixing the penis comprises a first fixing air bag 201 and a second fixing air bag 202, and the air bag 21 for pressing the penis is located between the first fixing air bag 201 and the second fixing air bag 202. Figure 2 As shown, the first fixing air bag 201 and the second fixing air bag 202 in this embodiment are schematic diagrams of the pressing force on the penis, and from the diagram, it can be seen that the stress points a and b on the first fixing air bag 201 and the stress points a' and b' on the second fixing air bag 202 form a square stress structure on the penis. After inflation, the stress points a and b on the first fixing air bag 201 and the stress points a' and b' on the second fixing air bag 202 first contact and press the sponge on the penis, and the material on the top of the first fixing air bag 201 and the second fixing air bag 202 is thicker than that at other positions, so that the deformation amount of the top of the first fixing air bag 201 and the second fixing air bag 202 during inflation is smaller than that at other positions. Therefore, the pressing force obtained by the side surface and the lower surface of the penis is greater than that obtained by the top of the penis, so that the large blood vessels on the top of the penis will not be subjected to the same pressing force as the side surface and the lower surface of the penis, which ensures that the first fixing air bag 201 and the second fixing air bag 202 can better fix the device on the penis without pressing the large artery on the top of the penis when inflated, thereby further improving the safety and reliability of the device.

[0026] As shown, Figure 3As shown, in this embodiment, the inner wall of the top of the air bag 20 for fixing the penis is provided with a gap 3 corresponding to the large artery of the penis. Since the structure of the penis is oval, when the device is sleeved on the penis, the side and lower surface of the penis first contact the air bag. During the inflation process of the air bag for fixing the penis 20, the side and lower surface of the penis first bear the extrusion force. Since the material of the top of the air bag for fixing the penis 20 is thicker than other parts, the deformation of the top is smaller than that of other parts of the air bag for fixing the penis 20, so that a certain gap 3 is left between the top of the air bag for fixing the penis 20 and the penis during the inflation process. Although the skin of the top of the penis is in contact with the air bag for fixing the penis 20 during the extrusion of the air bag for fixing the penis 20, the force borne by the top is smaller than that borne by other parts, so that the large artery of the top of the penis is not extruded by the air bag for fixing the penis 20, effectively avoiding the risk of tissue necrosis caused by ischemia of the large artery of the penis due to extrusion.

[0027] In this embodiment, the air bag for fixing the penis 20 includes an arc-shaped main body 203 and a buffer part 204 at the end of the main body. Specifically, the air bag for fixing the penis 20 adopts an L-shaped arc design similar to the penis, and the buffer part 204 at the end is an arc-shaped protrusion. When the air bag for fixing the penis 20 is inflated, the side of the main body 203 and the buffer part 204 at the end first contact the sponge of the lower surface of the penis to generate an inward extrusion force on the penis. By generating an inward extrusion force on the sponge of the lower surface and both sides of the penis, the device can be better fixed on the penis. At the same time, the buffer part at the end of the main body 203 is designed as an arc-shaped protrusion, which can better fit the lower surface of the penis and prevent the device from rotating on the penis when the air bag extrudes the penis, thereby affecting the urine control effect of the device. Therefore, the buffer part 204 at the end of the main body 203 further improves the stability of the device fixed on the penis and enhances the urine control effect of the device.

[0028] In addition, the inward movement distance of the top of the arc-shaped main body 203 is smaller than that of the buffer part 204 at the end of the main body. The material of the top of the air bag for fixing the penis 20 is thicker than that of the buffer part 204, so that the deformation of the top of the air bag for fixing the penis 20 during the inflation process is smaller than that of the buffer part 204. At the same time, in order to better fix the device on the penis, the required extrusion force of the lower surface of the penis is greater than that of the top, so that the inward movement distance of the buffer part 204 is greater than that of the top of the air bag for fixing the penis 20. The inward movement distance of the air bag for fixing the penis 20 is small, which is also beneficial to avoid extruding the large artery of the top of the penis, thereby improving the safety and stability of the device.

[0029] The main body 203 of the penis fixing air bag 20 has a first elastic part 4 which is retractable, and the main body 203 of the penis fixing air bag 20 is retracted or extended along the center of the ring 1 through the first elastic part 4. The penis fixing air bag 20 is fixed on the penis through the extension and retraction of the first elastic part 4, and the first elastic part 4 is in a corrugated shape. In the un-inflated state, the first elastic part 4 is retracted on the inner wall of the ring 1, and in the inflated state, the first elastic part 4 is expanded along the center of the ring 1 to press the penis, thereby achieving the effect of the fixing device. In addition, the first elastic part 4 in the corrugated shape also has a certain concentration effect. Specifically, in the inflated state of the penis fixing air bag 20, the first elastic part 4 can extend the pressing force of the penis fixing air bag 20 along the center of the ring 1. Compared with the existing air bag in a circular or columnar shape, the first elastic part 4 in the corrugated shape can better concentrate the pressing force of the penis fixing air bag 20 to the center of the ring 1, so as to ensure that the air of the buffer part 204 of the penis fixing air bag 20 does not spread everywhere, causing the penis fixing air bag 20 to deform and hinder the inward movement of the penis pressing air bag 21.

[0030] In this embodiment, the main body 203 of the penis fixing air bag 20 is provided with a smooth first contact surface 5, and the first contact surface of the main body 203 of the penis fixing air bag 20 is in contact with the penis after inflation. The first contact surface 5 remains smooth whether it is in an inflated state or not, and the state of the first contact surface 5 does not change with the amount of inflation, which can further avoid the phenomenon that the first contact surface 5 of the main body 203 is wrinkled and clamped to the skin in the case of insufficient inflation. In the inflated state of the main body 203 of the penis fixing air bag 20, the first contact surface 5 is fully in contact with the skin on the surface of the penis, so that the surface in contact with the penis is fully stressed, which not only plays the role of the fixing device but also improves the comfort of the user. In addition, the first contact surface 5 has a certain width, which greatly expands the contact area of the first contact surface 5 and the skin of the penis. The penis fixing air bag 20 can expand the stress area of the penis during inflation, avoid congestion caused by small area pressing the penis, and also avoid leaving marks on the penis caused by long-term pressing of the penis fixing air bag 20, thereby affecting the comfort of the user.

[0031] The air bag 21 for pressing the penis has a second elastic part 41 with side edges that can be extended and retracted, and a second contact surface 51 located at the top of the air bag 21 for pressing the penis, which is extended and retracted along the central position of the ring 1 by the second elastic part 41. The air bag 21 for pressing the penis is in the shape of a column and is arranged on the inner wall of the ring 1, and the second elastic part 41 has a certain elastic force, like the first elastic part 4, which can concentrate the pressing force in the air bag 21 for pressing the penis to the central position, avoiding the deformation of the air bag 21 for pressing the penis to the four directions. When urination is needed, the contraction force of the second elastic part 41 can also contract the air bag 21 for pressing the penis on the inner wall of the ring 1, without pressing the urethra, which can ensure that the urethra is completely open for urination. In addition, the second elastic part 41 has a certain buffering effect when the air bag 21 for pressing the penis presses the penis, because the urethra under the surface of the penis has a certain elasticity, when the air bag 21 for pressing the penis has a large amount of air, the second elastic part 41 can rebound part of the force to the pressing air bag, avoiding the excessive pressing force of the air bag affecting the pressing effect of the urethra.

[0032] As shown in Figure 4 , it is a force diagram between the air bag for fixing the penis and the air bag for pressing the penis in this embodiment, and the force inside the air bag 21 for pressing the penis is counteracted by the pressing force generated by the side of the air bag 20 for fixing the penis during the process of pressing the urethra, so that the large artery at the top of the penis is not pressed. As shown in Figure 3 , it is a force diagram between the air bag 21 for pressing the penis and the air bag 20 for fixing the penis in this embodiment, and the air bag 20 for fixing the penis is inflated, and the deformation amount of the top of the air bag is less than that of the side and the buffer part 203, so that the force points a on the first fixing air bag 201 and the force points a' on the second fixing air bag 202 of the air bag 20 for fixing the penis become the main force points, and when the air bag 21 for pressing the penis presses the penis inward, the counterforce generated by the force points c near the top of the side of the penis is counteracted, at this time, the force generated by the force points a on the first fixing air bag 201 and the force points a' on the second fixing air bag 202 of the air bag 20 for fixing the penis is balanced with the force generated by the force points c on the air bag 21 for pressing the penis, forming a balanced triangular force structure, which can avoid the large artery of the penis being pressed by the force generated by the lower surface of the penis when the air bag 21 for pressing the penis presses the penis.

[0033] In this embodiment, the distance of inward movement of the air bag 21 for pressing the penis is greater than the distance of inward movement of the air bag 21 for fixing the penis. Since the urethra and the sponge on the urethra of the penis are elastic, the air bag 21 for pressing the penis needs to move inward a greater distance to press the urethra to achieve the effect of closing the urethra. If the distance of inward movement of the air bag 21 for pressing the penis is the same as the distance of inward movement of the air bag 20 for fixing the penis, it can only play the same fixing role as the air bag 20 for fixing the penis and cannot achieve the effect of pressing the urethra. Therefore, only when the distance of inward movement of the air bag 21 for pressing the penis is greater than the distance of inward movement of the air bag 20 for fixing the penis can the effect of pressing the urethra be achieved, and the required inflation amount in the air bag 21 for pressing the penis is also greater than the inflation amount in the air bag 20 for fixing the penis.

[0034] In this embodiment, as shown in Figure 5 The device also includes an inflation port 6 for inflation, the inflation port 6 includes a fixed inflation port 61 and a pressing inflation port 62, the first fixed air bag 201 and the second fixed air bag 202 are interconnected, the fixed inflation port 61 inflates the first fixed air bag 201 and the second fixed air bag 202 at the same time, and the pressing inflation port 62 inflates the air bag 21 for pressing the penis. The fixed inflation port 61 and the pressing inflation port 62 are in a pagoda structure, which can prevent the connected organs from falling off, and the fixed inflation port 61 and the pressing inflation port 62 are vertically arranged on the outer wall of the annular ring 1. When the device is fitted on the penis, the fixed inflation port 61 and the pressing inflation port 62 are parallel to the penis, which can avoid the patient from rubbing against clothes during use, affecting the patient's use. After the device is fitted on the penis, the fixed inflation port 61 inflates the first fixed air bag 201 and the second fixed air bag 202, and the stress points a and b on the first fixed air bag 201 and the stress points a' and b' on the second fixed air bag 202 inwardly press the sponge of the penis to fix the first fixed air bag 201 and the second fixed air bag 202 on the penis. Then, the pressing inflation port 62 inflates the air bag 21 for pressing the penis through the annular air channel 7, and the air bag 21 for pressing the penis moves towards the center of the annular ring 1 to press the urethra, thereby achieving the effect of closing the urethra. When urination is needed, the air in the air bag 21 for pressing the penis is emptied through the pressing inflation port 62, and the pressing force on the lower end of the urethra is removed, so that the urethra is opened.

[0035] In summary, the external artificial urethral sphincter device provided by the application can realize the effects of fixing the device on the penis and freely controlling urine through the double-bag structure design, wherein the penis-fixing air bag is arranged in a similar structure in combination with the structure of the penis, the penis-fixing air bag is arranged to concentrate the extrusion force on the contact sponge body surface when extruding the penis, thereby reducing the extrusion force on the top of the penis-fixing air bag, and the material on the top of the penis-fixing air bag is thicker than other parts, so that the deformation amount of the material on the top of the penis-fixing air bag is smaller than that of other positions, so that the large blood vessels on the top of the penis are not extruded, and the safety of the device is improved. In addition, the penis-extruding air bag is arranged between the first fixing air bag and the second fixing air bag, the freely controlling urine effect is realized by controlling the inward movement distance of the penis-extruding air bag, and since the sponge body of the penis and the urethra both have elasticity, the inward movement distance of the penis-extruding air bag is greater than the inward movement distance of the penis-fixing air bag, so that the effect of closing the urethra can be realized.

[0036] Although the present application has been disclosed by the preferred embodiments as above, it is not intended to limit the present application, and any person skilled in the art can make some changes and modifications without departing from the spirit and scope of the present application, so the protection scope of the present application shall be subject to the scope required by the claims.

Claims

1. An external artificial urethral sphincter device, characterized in that, The device includes: an annular ring for fitting onto the penis and an airbag located on the inner wall of the annular ring. The airbag includes an airbag for fixing the penis and an airbag for compressing the penis. The airbag for fixing the penis includes a first fixing airbag and a second fixing airbag, and the airbag for compressing the penis is located between the first fixing airbag and the second fixing airbag. The inward movement distance of the airbag for compressing the penis is greater than the inward movement distance of the airbag for fixing the penis. In use, the annular ring is fitted onto the penis, and the airbag for fixing the penis is first inflated to securely fix the annular ring onto the penis. Then, the airbag for compressing the penis is inflated. The penile balloon is inflated, and the balloon used to compress the penis compresses the urethra on the lower surface of the penis, allowing the urethra to freely close for urination. The material at the top of the balloon used to fix the penis is thicker than other parts, and its deformation is smaller than other locations. This creates a balanced triangular force structure between the force points on the first and second fixing balloons and the force point on the balloon used to compress the penis, thus preventing compression of the aorta at the top of the penis. When urination is needed, the air in the balloon used to compress the penis is deflated, removing the compressive force on the lower surface of the penis, thereby achieving the effect of urination.

2. The external artificial urethral sphincter device according to claim 1, characterized in that, The inner wall of the top of the air bladder used to fix the penis has a corresponding gap with the penile aorta.

3. The external artificial urethral sphincter device according to claim 2, characterized in that, The airbag for fixing the penis includes an arc-shaped main body and a buffer section located at the end of the main body.

4. The external artificial urethral sphincter device according to claim 3, characterized in that, The inward movement distance of the top of the arc-shaped main body is less than the inward movement distance of the buffer part at the end of the main body.

5. The external artificial urethral sphincter device according to claim 4, characterized in that, The main body of the airbag for fixing the penis has a first elastic part that is retractable on the side, and the main body of the airbag for fixing the penis extends and retracts relative to the center position of the annular ring through the first elastic part.

6. The external artificial urethral sphincter device according to claim 5, characterized in that, The main body of the airbag for fixing the penis has a smooth first contact surface, and the first contact surface of the main body of the airbag for fixing the penis fits against the penis after inflation.

7. The external artificial urethral sphincter device according to claim 1, characterized in that, The airbag for squeezing the penis has a second elastic portion that is retractable on the side and a second contact surface located at the top of the airbag for squeezing the penis. The airbag for squeezing the penis extends and retracts relative to the center position of the annular ring through the second elastic portion.

8. The external artificial urethral sphincter device according to claim 1, characterized in that, The device further includes an inflation port for inflation, which includes a fixed inflation port and a compression inflation port. The first fixed airbag and the second fixed airbag are interconnected. The fixed inflation port inflates both the first fixed airbag and the second fixed airbag simultaneously. The compression inflation port inflates the airbag used for compressing the penis.

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